Regional Anesthesia for Percutaneous Transluminal Angioplasty

Percutaneous Transluminal Angioplasty Clinical Trial

Official title:

The Effect of Regional Anesthesia Method on Tissue Oxygenation in Patients Who Will Undergo Percutaneous Transluminal Angioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737225
• Other study ID #: 775 (24.10.2022)
• Status: Completed
• Start date: September 24, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: December 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the effects of regional anesthesia method applied in patients who will undergo percutaneous transluminal angioplasty for lower extremity revascularization will be investigated comparatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 1, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age: > 18 years

• Peripheral artery occlusive disease

• Eligibility for PTA

Exclusion Criteria:

• Patients' refusal

• Under the age of 18

• Language problems (not knowing turkish)

• Psychological or mental disorders.

• Disturbance of Conscious level.

• Uncooperative patients

• Those who are allergic to anesthetic drugs to be used

• Those with contraindications for the application of peripheral nerve block (coagulopathy, skin infection at the block site)

• need for endotracheal intubation or general anesthesia

Related Conditions & MeSH terms

• Percutaneous Transluminal Angioplasty
• Peripheral Arterial Disease
• Peripheral Artery Occlusive Disease

Intervention

Device:
• Near Infrared Spectroscopy (NIRS)
We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Oxygenation	Tissue oxygenation will be measured from both lower extremities by Near Infrared Spectroscopy for 30 min after popliteal sciatic nerve block and during procedure.	During procedure
Secondary	Body Temperature of Lower Extremities	Body temperature will be measured simultaneously at 0-5-10-15-20-25 and 30th minutes after the application of the popliteal sciatic nerve block	During procedure
Secondary	Patient Satisfaction Score	Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.	15 minutes after procedure
Secondary	Surgeon Satisfaction Score	Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.	15 minutes after procedure